Role and Mechanism of Probiotics in Improving Motor Symptoms in Mild to Moderate Parkinson's Disease

  • STATUS
    Recruiting
  • End date
    Dec 18, 2023
  • participants needed
    240
  • sponsor
    Beijing Friendship Hospital
Updated on 25 January 2022
constipation
levodopa
parkinson's disease
benserazide
motor symptoms
Accepts healthy volunteers

Summary

This study is a multicenter randomized double-blind placebo-controlled study. The research content is 1. The improvement effect of Bifidobacterium triple viable capsulesBIFICO on motor symptoms and constipation and sleep in mild to moderate Parkinson's disease and the safety of the study; 2. the mechanism of the improvement effect of intestinal microecological changes on motor and constipation symptoms in mild to moderate Parkinson's disease.

Description

This was a multicenter randomized double-blind placebo-controlled study that included 240 patients with primary PD with modified H-Y stage 1-3, randomly divided into treatment and placebo control groups; On the basis of the original PD medication, the treatment group was given bifidobacterium triple viable capsules (BIFICO) and the control group was given placebo; Patients who met the diagnosis of constipation were given Macrogol 4000 powder and /or Enema glycerine as a rescue medicine, and the observation period was 12+12 weeks.

All subjects underwent the World Movement Disorders Society Parkinson's Disease Comprehensive Rating Scale (MDS-UPDRS), Rome IV Constipation Diagnostic Scale, Cleveland Rating Scale, Parkinson's Disease Sleep Scale-2 (PDSS-2), and General Clinical Outcome Inventory (CGI) scores before and after treatment, and also recorded the patients' single bowel movement time and the use of Macrogol 4000 powder and Enema glycerine , to investigate the improvement effect of Bifido on motor symptoms and non-motor symptoms in PD patients. For the above patients, stool and blood samples were collected at the time of enrollment and at 12 weeks of observation.

At the same time,120 age-and gender-matched healthy adults without constipation were recruited, and their stool and blood samples were collected; the stool samples of PD patients before and after treatment and healthy controls were subjected to the determination of fecal flora 16S DNA abundance. Stool samples of 10 PD patients and 10 healthy controls were taken from each group for metagenomic sequencing. Detection of small molecule metabolites, PD-related genes in blood. To investigate the effect of BIFICO on levodopa pharmacokinetics, levodopa pharmacokinetic measurements will be performed at Friendship Hospital. For patients who agree to participate and sign the informed consent form, blood specimens will be collected consecutively at Visit 2 and Visit 11 after taking Levodopa and Benserazide Hydrochloride Tablets for levodopa blood concentration measurement.

Details
Condition Parkinson Disease, Parkinsonian Disorders, Basal Ganglia Diseases, Brain Diseases, Movement Disorders, Neurodegenerative Diseases, Central Nervous System Diseases, Nervous System Diseases
Treatment Placebo, Live Combined Bifidobacterium,Lactobacillus and Enterococcus Capsules
Clinical Study IdentifierNCT04871464
SponsorBeijing Friendship Hospital
Last Modified on25 January 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 40-80 years old, both male and female
Patients with primary Parkinson's disease who meet the 2015 MDS clinical diagnostic criteria; PD with modified Hoehn-Yahr stage 1-3 and MDS-UPDRS II+III score 14 and no significant off periods or off periods 1.5 hours per day (excluding morning motor inability)
Pre-enrollment therapeutic medications included Levodopa and Benserazide Hydrochloride Tablets, and all Parkinson's disease medications were unadjusted and motor symptoms were stable for 28 days prior to enrollment
No probiotic or/and prebiotic (including lactulose) and antibiotic therapy for 60 days prior to enrollment, and if so, a 60-day washout period
Understand and agree to follow the study protocol, agree to be enrolled and sign the informed consent form

Exclusion Criteria

Parkinson's superimposed syndrome and secondary Parkinson's syndrome, such as multiple system atrophy, progressive supranuclear palsy, etc
Taking any probiotic or prebiotic (including lactulose) within 60 days prior to enrollment; having inflammation at any site and using any antibiotic within 60 days prior to enrollment; or having blood leukocytes above the upper limit of normal at screening
Combined endocrine disorders, such as history of diabetes or fasting glucose 7.8 mmol/L, hyper- or hypothyroidism, adrenal tumors, abnormal pituitary function, etc
Comorbid other neurological disorders, such as cognitive impairment, Mini-Mental State ExaminationMMSE scale score <24; severe anxiety states and/or severe depressive states (Hamilton Depression Inventory-17 item score >17, Hamilton Anxiety Scale score 14, or being treated with antidepressant anxiety medication); malignancy, spinal cord lesions, epilepsy, autonomic disorders (urinary retention, urinary incontinence, or upright hypotension , blood pressure drop 30/15 mmHg at any time point within 5 minutes of uprightness), etc.; new cerebrovascular disease or sequelae of severe cerebrovascular disease within 6 months, which affects the assessment
Gastrointestinal tumors, history of inflammatory bowel disease, other acute and chronic inflammation of the gastrointestinal tract (including acute attacks of cholecystitis) within 3 months
History of gastrointestinal surgery (excluding endoscopic resection of gastrointestinal benign polyps, appendicitis resection) or constipation caused by surgery
History of anal fissure, perianal abscess, irreversible anal prolapse, pelvic trauma
Severe cardiovascular disease (such as congestive heart failure with a heart function classification of - by the American Heart Association, a history of myocardial infarction within 6 months, etc.)
Severe liver and kidney dysfunction with glutamate-pyruvate transaminase, aspartate transaminase and total bilirubin 1.5 times higher than the upper limit of normal; serum creatinine 1.5 times higher than the upper limit of normal
Pregnant and lactating women or women of childbearing age (40-60 years) who are human chorionic gonadotropin (HCG)-positive
Known allergy to test drugs or related products
People with a history of drug abuse or alcohol dependence
Those who have participated in other clinical trials within 3 months prior to enrollment
Refusal to enroll and inability to cooperate with the investigator; patients judged by the investigator to be unsuitable for enrollment
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